{"commentary":{"count":618,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":239,"youtube":220,"podcast":146,"x_video":13},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04964934\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"SERENA-6","nct_id":"NCT04964934","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=serena-6-nct04964934. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"SERENA-6","arms":[{"description":"The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150,100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (PO, once daily) or letrozole placebo (PO, once daily)","label":"AZD9833 + palbociclib, abemaciclib or ribociclib","type":"EXPERIMENTAL"},{"description":"The patients will recieve anastrozole (1 mg, PO, once daily) or letrozole (2.5 mg, PO, once daily) + palbociclib (PO, once daily, 125, 100 or 75 mg for 21 consecutive days followed by 7 days off treatment), abemaciclib (PO, twice daily, 150, 100 or 50 mg) or ribociclib (To Be Determined, PO, once daily for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily)","label":"Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-09-01","type":"ESTIMATED"},"conditions":["ER-Positive HER2-Negative Breast Cancer"],"enrollment":{"count":315,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"AZD9833","type":"DRUG"},{"name":"AZD9833 Placebo","type":"DRUG"},{"name":"Anastrozole","type":"DRUG"},{"name":"Anastrozole placebo","type":"DRUG"},{"name":"Letrozole","type":"DRUG"},{"name":"Letrozole placebo","type":"DRUG"},{"name":"Palbociclib","type":"DRUG"},{"name":"Abemaciclib","type":"DRUG"},{"name":"Luteinizing hormone-releasing hormone (LHRH) agonist","type":"DRUG"},{"name":"Ribociclib","type":"DRUG"}],"last_update":"2026-09-23","lead_sponsor":"AstraZeneca","official_title":"A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-06-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST version 1.1)","timeFrame":"From randomization until the earlier of the progression event or death (approximately 2 years)"}],"references":[{"citation":"Brufsky A, Park YH, Bidard FC, Mayer EL, Janni W, Ma C, Cristofanilli M, Bianchini G, Iwata H, Fasching PA, Nowecki Z, Pascual J, Chen SC, Moreau L, Ruiz-Borrego M, Shai A, Karadurmus N, Jung KH, Kikawa Y, Baird RD, Habash R, Sugarman R, Fox S, Selvi Miralles M, Huang Bartlett C, Turner N. SERENA-6 visual patient-reported outcomes and safety: camizestrant for emerging ESR1m advanced breast cancer during first-line endocrine-based therapy. Oncologist. 2026 Aug 6;31(9):oyag278. doi: 10.1093/oncolo/oyag278.","pmid":"42496653","type":"DERIVED"},{"citation":"Turner NC, Mayer EL, Park YH, Janni W, Ma C, Cristofanilli M, Bianchini G, Kalinsky K, Iwata H, Chia S, Brufsky AM, Fasching PA, Nowecki Z, Pascual J, Karadurmus N, Gal-Yam E, Chung WP, Im SA, Zambelli A, Dalenc F, Oliveira M, Ishiguro H, Huang CS, Klinowska T, Fox S, Morrow C, Robert L, Huang-Bartlett C, Bidard FC. Switching to camizestrant at ESR1 mutation emergence before disease progression during first-line treatment of hormone receptor-positive advanced breast cancer (SERENA-6): extended analysis of a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):941-958. doi: 10.1016/S1470-2045(26)00287-1. Epub 2026 Jul 13.","pmid":"42442380","type":"DERIVED"},{"citation":"Bidard FC, Mayer EL, Park YH, Janni W, Ma C, Cristofanilli M, Bianchini G, Kalinsky K, Iwata H, Chia S, Fasching PA, Brufsky A, Nowecki Z, Pascual J, Moreau L, Chen SC, Karadurmus N, Gal-Yam EN, Jung KH, Pernas S, McClain S, He W, Klinowska T, Huang-Bartlett C, Turner NC; SERENA-6 Study Group. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Aug 7;393(6):569-580. doi: 10.1056/NEJMoa2502929. Epub 2025 Jun 1.","pmid":"40454637","type":"DERIVED"},{"citation":"Turner N, Huang-Bartlett C, Kalinsky K, Cristofanilli M, Bianchini G, Chia S, Iwata H, Janni W, Ma CX, Mayer EL, Park YH, Fox S, Liu X, McClain S, Bidard FC. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol. 2023 Mar;19(8):559-573. doi: 10.2217/fon-2022-1196. Epub 2023 Apr 18.","pmid":"37070653","type":"DERIVED"}],"start_date":{"date":"2021-06-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)","url":"https://clinicaltrials.gov/study/NCT04964934"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/serena-6-nct04964934"}